(186 days)
The LOGIC Stand-Alone Intervertebral Body Fusion Device is indicated for stand-alone intervertebral body fusion in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The LOGIC Stand-Alone Intervertebral Body Fusion Device is to be used with autogenous bone graft material.
The LOGIC system consists of a PEEK spacer with titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. Spacers are available in a variety of widths. depths, and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the lumbar spine. The screws are intended to be used as integrated fixation for stand-alone use of the device.
The provided regulatory document describes a 510(k) premarket notification for the "LOGIC Stand-Alone Intervertebral Body Fusion Device." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for efficacy and safety from scratch.
Therefore, the information regarding acceptance criteria and a study proving device performance, as typically understood for AI/software-as-a-medical-device (SaMD) or novel device submissions, is not present in this document. Instead, the "performance data" refers to non-clinical bench testing to demonstrate mechanical equivalence.
Here's the breakdown of what can be extracted based on your request, explicitly stating what information is not available due to the nature of a 510(k) for this type of device:
Acceptance Criteria and Device Performance for the LOGIC Stand-Alone Intervertebral Body Fusion Device
The LOGIC Stand-Alone Intervertebral Body Fusion Device, a Class II medical device, demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing. The acceptance criteria for this type of device are primarily tied to meeting established ASTM standards for intervertebral body fusion devices, ensuring the device's mechanical integrity and performance under simulated physiological conditions.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance Statement |
|---|---|
| Static and dynamic axial compression (ASTM F2077-11) | "The results of this non-clinical testing show that the LOGIC device is substantially equivalent to the predicate devices." |
| Static and dynamic compressive shear (ASTM F2077-11) | "The results of this non-clinical testing show that the LOGIC device is substantially equivalent to the predicate devices." |
| Static Subsidence (ASTM F2267-04) | "The results of this non-clinical testing show that the LOGIC device is substantially equivalent to the predicate devices." |
| Static Expulsion (ASTM Draft Standard F-04.25.02.02) | "The results of this non-clinical testing show that the LOGIC device is substantially equivalent to the predicate devices." |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "test set" here refers to the physical devices subjected to mechanical bench testing, not a dataset of patient images or clinical outcomes. Specific numbers of devices tested per standard are not provided in this summary, but typically multiple samples are used for each test.
- Data Provenance: The data is generated from in vitro mechanical testing performed on the device itself.
- Retrospective or Prospective: Not applicable, as this is bench testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective measurements against engineering standards, not expert clinical interpretation.
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Adjudication method for the test set: Not applicable. Mechanical test results are quantitative and do not require expert adjudication in the same way clinical diagnoses do.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used: For mechanical testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., force applied, displacement, cycles to failure) and comparison to the performance of predicate devices or established minimum thresholds set by the ASTM standards.
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The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established: Not applicable.
Summary of Substantial Equivalence:
The submission highlights that the LOGIC device is substantially equivalent to its predicates (Biomet Solitaire PEEK Anterior Spinal System, Binder Intervertebral Body Fusion Device, Synthes Synfix-LR system, Centinel Spine STALIF system) in terms of:
- Intended use
- Design
- Materials (PEEK-OPTIMA®, tantalum markers, titanium alloy screws)
- Processing
- Operational principles
The non-clinical mechanical performance data further supports this claim of substantial equivalence.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.